卡格列净非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003732793739633751603733903743943740370.21
211.033738503728513733500.19
单位质量响应值RSD%判断
34003.3633848.590.33数据可信
供试品溶液-6012603批-非奈利酮-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1177970-17797047.16639.1116.0047.1739.1116.00
2125194-12519433.17933.18
3127417-12741733.76833.77
4131608-13160834.87934.88
5173978-17397846.10846.11
6149208-14920839.54339.54
10min1300348-30034879.59874.705.4279.6874.775.43
2278214-27821473.73273.79
3268834-26883471.24671.30
4261290-26129069.24769.31
5295734-29573478.37578.45
6286817-28681776.01276.08
15min1340003-34000390.10788.222.6290.3288.412.63
2338089-33808989.60089.78
3324785-32478586.07486.25
4319862-31986284.77084.94
5340881-34088190.34090.55
6333667-33366788.42888.62
20min1362958-36295896.19194.721.0696.5595.051.07
2360366-36036695.50495.83
3355054-35505494.09694.41
4352388-35238893.39093.70
5356622-35662294.51294.87
6357011-35701194.61594.95
30min1376805-37680599.86199.490.61100.3899.990.60
2377814-377814100.128100.61
3376631-37663199.815100.29
4376129-37612999.682100.15
5372957-37295798.84199.36
6372179-37217998.63599.13
45min1384032-384032101.776101.650.94102.46102.300.92
2387480-387480102.690103.34
3385467-385467102.156102.80
4385877-385877102.265102.90
5380134-380134100.743101.42
6378252-378252100.244100.91
60min1386646-386646102.469102.551.32103.33103.381.30
2390184-390184103.406104.23
3391504-391504103.756104.57
4391676-391676103.802104.61
5381845-381845101.196102.04
6379883-379883100.676101.51
极限1387985-387985102.824102.781.28103.85103.781.26
2388530-388530102.968103.97
3391457-391457103.744104.73
4394572-394572104.569105.55
5381591-381591101.129102.15
6382840-382840101.460102.46
卡格列净非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541644579164766916525511645057164857516476860.20
210.561647939164361916457790.19
单位质量响应值RSD%判断
156326.94155850.280.22数据可信
供试品溶液-6012603批-卡格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min175417-754174.2575.3333.924.265.3333.90
2100204-1002045.6565.66
384140-841404.7504.75
473497-734974.1494.15
576468-764684.3174.32
6156592-1565928.8398.84
10min1317097-31709717.90017.7213.9617.9117.7213.97
2370301-37030120.90320.91
3295565-29556516.68416.69
4242655-24265513.69813.70
5311989-31198917.61117.62
6345347-34534719.49419.51
15min1478951-47895127.03626.905.9627.0726.945.97
2508059-50805928.67928.72
3457123-45712325.80425.84
4430350-43035024.29324.32
5492153-49215327.78127.82
6492993-49299327.82927.88
20min1516098-51609829.13328.684.7629.2228.764.75
2480908-48090827.14727.24
3480601-48060127.12927.21
4502893-50289328.38828.46
5530633-53063329.95430.04
6536753-53675330.29930.39
30min1506352-50635228.58327.753.6628.7127.883.63
2483146-48314627.27327.41
3474281-47428126.77326.90
4511072-51107228.84928.97
5504587-50458728.48328.62
6469784-46978426.51926.66
45min1481608-48160827.18626.492.7427.3626.672.73
2472583-47258326.67726.86
3456712-45671225.78125.95
4452080-45208025.51925.69
5483550-48355027.29627.48
6468945-46894526.47126.66
60min1474183-47418326.76727.054.7026.9927.274.67
2474838-47483826.80427.03
3503226-50322628.40728.62
4446000-44600025.17625.38
5506204-50620428.57528.80
6470457-47045726.55726.79
极限1463428-46342826.16025.752.8126.4326.022.79
2444970-44497025.11825.39
3470190-47019026.54226.80
4439290-43929024.79725.05
5451375-45137525.48025.75
6467726-46772626.40326.68
卡格列净非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号D250501对照品来源原料对照品使用方法直接使用
对照品含量(%)99.9对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.003756513773793764923777903771653768950.23
211.033753943770113762020.31
单位质量响应值RSD%判断
34263.1834107.160.33数据可信
供试品溶液-6012603批-非奈利酮-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min169142-6914218.18523.7717.1318.1923.7817.12
289538-8953823.54923.55
3107466-10746628.26528.26
484516-8451622.22922.23
582425-8242521.67921.68
6109277-10927728.74128.74
10min1246314-24631464.78373.047.0464.8173.087.05
2280639-28063973.81173.85
3299045-29904578.65278.70
4273602-27360271.96072.00
5269497-26949770.88070.92
6297052-29705278.12878.18
15min1338036-33803688.90790.581.2289.0590.741.24
2344947-34494790.72590.89
3348885-34888591.76091.94
4342976-34297690.20690.36
5342451-34245190.06890.22
6348991-34899191.78891.97
20min1360135-36013594.71995.010.4795.0195.320.48
2363316-36331695.55695.87
3362873-36287395.43995.77
4359878-35987894.65294.96
5359333-35933394.50894.81
6361931-36193195.19295.52
30min1370251-37025197.38097.340.2597.8297.810.25
2370079-37007997.33597.81
3371810-37181097.79098.28
4369745-36974597.24797.71
5369289-36928997.12797.59
6369491-36949197.18097.67
45min1364945-36494595.98497.160.7396.5997.800.74
2371675-37167597.75498.39
3371744-37174497.77298.43
4369675-36967597.22897.86
5370835-37083597.53398.16
6367615-36761596.68697.34
60min1370315-37031597.39796.990.4698.1697.780.45
2369188-36918897.10097.90
3369295-36929597.12897.94
4367204-36720496.57897.37
5370325-37032597.39998.19
6366242-36624296.32597.14
极限1368258-36825896.85696.850.4097.7897.800.39
2369498-36949897.18298.14
3368473-36847396.91297.89
4366153-36615396.30297.25
5369957-36995797.30298.25
6366993-36699396.52397.50
卡格列净非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101567-202301对照品来源原料对照品使用方法直接使用
对照品含量(%)97.9对照品水分(%)0对照品稀释倍数100
标示量(mg)100供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.541654744166193916610621664846166315116611480.24
210.561653643166038816570160.29
单位质量响应值RSD%判断
157604.17156914.390.32数据可信
供试品溶液-6012603批-卡格列净-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1299602-29960216.78615.856.6616.7915.856.64
2288794-28879416.18116.18
3294503-29450316.50116.50
4254442-25444214.25614.26
5264114-26411414.79814.80
6295461-29546116.55416.55
10min1441396-44139624.73124.411.8524.7624.431.86
2438329-43832924.55924.59
3440102-44010224.65824.69
4427491-42749123.95223.98
5423528-42352823.73023.75
6442662-44266224.80224.83
15min1472202-47220226.45726.613.4126.5326.683.41
2457157-45715725.61425.68
3499281-49928127.97428.04
4474562-47456226.58926.65
5459371-45937125.73825.80
6487269-48726927.30127.37
20min1522216-52221629.25926.797.9529.3726.907.91
2418482-41848223.44723.56
3483563-48356327.09327.21
4513956-51395628.79628.90
5470580-47058026.36626.47
6459800-45980025.76225.88
30min1433766-43376624.30324.273.1124.4724.433.08
2426799-42679923.91324.06
3422039-42203923.64623.81
4419683-41968323.51423.67
5454927-45492725.48925.64
6442256-44225624.77924.94
45min1445786-44578624.97724.864.9725.1825.054.93
2435910-43591024.42324.61
3419868-41986823.52523.72
4484017-48401727.11927.31
5430731-43073124.13324.33
6445638-44563824.96925.17
60min1444169-44416924.88624.961.2325.1325.201.21
2447387-44738725.06725.30
3453919-45391925.43325.67
4446758-44675825.03125.27
5437384-43738424.50624.74
6443527-44352724.85025.09
极限1441142-44114224.71725.174.6025.0025.454.54
2453051-45305125.38425.66
3462838-46283825.93226.21
4448282-44828225.11725.40
5414991-41499123.25123.53
6475462-47546226.64026.92
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